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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, nephrostomy, general & plastic surgery
Product CodeGBO
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2017 422 422
2018 435 435
2019 175 175
2020 127 127
2021 115 115
2022 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 366 366
Material Separation 193 193
Fluid/Blood Leak 169 169
Difficult to Remove 147 147
Break 116 116
Detachment Of Device Component 107 107
Detachment of Device or Device Component 72 72
Air Leak 32 32
Disconnection 27 27
Difficult to Advance 27 27
Fitting Problem 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Material Deformation 20 20
Gas/Air Leak 20 20
Tear, Rip or Hole in Device Packaging 17 17
Component Falling 15 15
Obstruction of Flow 13 13
Crack 12 12
Device Contamination with Chemical or Other Material 12 12
Material Integrity Problem 10 10
Device Contaminated During Manufacture or Shipping 10 10
Migration or Expulsion of Device 10 10
Device Operates Differently Than Expected 10 10
Device Dislodged or Dislocated 10 10
Failure to Advance 9 9
Aspiration Issue 8 8
Fracture 8 8
Material Twisted/Bent 8 8
Unsealed Device Packaging 7 7
Connection Problem 6 6
Material Rupture 6 6
Torn Material 5 5
Material Split, Cut or Torn 5 5
Complete Blockage 5 5
Material Fragmentation 4 4
Defective Component 4 4
Sticking 4 4
Appropriate Term/Code Not Available 4 4
Material Puncture/Hole 4 4
Defective Device 4 4
Use of Device Problem 3 3
Device Slipped 3 3
Separation Problem 3 3
Output Problem 3 3
Material Frayed 3 3
Difficult to Insert 3 3
Delivered as Unsterile Product 3 3
Migration 3 3
Device-Device Incompatibility 2 2
Partial Blockage 2 2
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Hole In Material 2 2
Device Damaged by Another Device 2 2
Patient-Device Incompatibility 2 2
Infusion or Flow Problem 2 2
Patient Device Interaction Problem 2 2
Loose or Intermittent Connection 2 2
Entrapment of Device 2 2
Positioning Problem 2 2
Insufficient Information 2 2
Activation, Positioning or Separation Problem 2 2
Mechanical Problem 2 2
Nonstandard Device 1 1
Stretched 1 1
Disassembly 1 1
Flushing Problem 1 1
Material Perforation 1 1
Component Missing 1 1
Deformation Due to Compressive Stress 1 1
Structural Problem 1 1
Split 1 1
Failure to Cut 1 1
Therapeutic or Diagnostic Output Failure 1 1
Filtration Problem 1 1
No Flow 1 1
Difficult to Open or Close 1 1
Moisture or Humidity Problem 1 1
Malposition of Device 1 1
Kinked 1 1
Moisture Damage 1 1
Occlusion Within Device 1 1
Mechanical Jam 1 1
Out-Of-Box Failure 1 1
Device Packaging Compromised 1 1
Expulsion 1 1
Component Incompatible 1 1
Positioning Failure 1 1
Bent 1 1
Contamination 1 1
Difficult to Fold, Unfold or Collapse 1 1
Device Inoperable 1 1
Improper Device Output 1 1
Contamination of Device Ingredient or Reagent 1 1
Physical Resistance/Sticking 1 1
No Pressure 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 534 534
No Code Available 383 383
No Clinical Signs, Symptoms or Conditions 169 169
No Consequences Or Impact To Patient 137 137
No Patient Involvement 88 88
Foreign Body In Patient 23 23
No Information 22 22
Insufficient Information 18 18
Pain 13 13
Pneumothorax 11 11
Failure of Implant 8 8
Hemorrhage/Bleeding 8 8
Discomfort 6 6
Device Embedded In Tissue or Plaque 6 6
Death 5 5
Inflammation 4 4
Fistula 4 4
Sepsis 3 3
Fever 2 2
Perforation 2 2
Abscess 2 2
Cognitive Changes 2 2
Unspecified Infection 2 2
Urinary Retention 2 2
Bacterial Infection 1 1
Bradycardia 1 1
Peritonitis 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Bowel Perforation 1 1
Fluid Discharge 1 1
Convulsion/Seizure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Erosion 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Paralysis 1 1
Pleural Effusion 1 1
Injury 1 1
Blood Loss 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Unspecified Kidney or Urinary Problem 1 1
Air Embolism 1 1
Aneurysm 1 1
Staphylococcus Aureus 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Mar-18-2018
2 Cook Inc. II Jan-16-2020
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